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New Indication FDA Approved for BAVENCIO

7/8/2020

We are pleased to announce that on June 30, 2020 the U.S. Food and Drug Administration (FDA) approved BAVENCIO® (avelumab) Injection 20 mg/mL for a new indication. BAVENCIO is co-developed and co-commercialized by EMD Serono and Pfizer Inc.


BAVENCIO was originally approved by the FDA on March 23, 2017 under Accelerated Approval, and EMD Serono has executed a signed Medicaid National Drug Rebate Agreement.


Please refer to the revised Full Prescribing Information for BAVENCIO.


We are respectfully requesting that you update your claims processing system(s), and any applicable coverage policies to reflect this new indication. NOTE: The national Level II Healthcare Common Procedure Coding System (HCPCS) J-code for BAVENCIO is J9023 (injection, avelumab, 10mg), and the 11-digit NDC is 44087-3535-01.


https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761049Orig1s009ltr.pdf


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